DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-36 were originally filed January 17, 2020.
The amendment received May 26, 2020 amended claims 3-9, 12, 14, 16-18, 20, 21, 24, 29-32, and 35 and canceled claims 10, 13, 15, 19, 22, 23, 33, and 34.
The amendment received December 1, 2023 amended claims 1 and 7-9.
The amendment received June 13, 2024 amended claims 1, 2, 4-9, 11, 12, 14, 16-18, 20, and 21; cancelled claim 3; and added new claim 37.
The amendment received February 25, 2025 amended claims 1, 8, 9, and 37. Please note: several claims have the incorrect status identifier.
The amendment received January 15, 2026 amended claims 1, 6, 11, 14, and 29 and cancelled claim 7.
Claims 1, 2, 4-6, 8, 9, 11, 12, 14, 16-18, 20, 21, 24-32, and 35-37 are currently pending.
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-9, 11, 12, 14, 16-18, 20, 21, and 24-30) in the reply filed on December 1, 2023. Claims 31, 32, 35, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicants elected, without traverse, SEQ ID NO: 1, a B cell epitope and a T cell epitope, PEG-3000, SEQ ID NO: 4, and a supermolecular complex as the species in the reply filed on December 1, 2023. Claims 4, 7, 14, and 25-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Please note: applicants elected subgenuses for several of the species, therefore, the subgenuses were searched. In addition, if the particulars of the species or subgenuses could not be readily ascertained from the specification, the claims directed to the nonelected species or subgenuses were withdrawn (e.g. SEQ ID NO: 1 forms b-sheets therefore, the claim to the alpha helix was withdrawn; applicants did not supply the chemical formula for PEG-3000 and the formulas was not recited in the specification so claim 14 was withdrawn, etc.).
Please note: regarding the arguments made in the response received June 13, 2024, see the following:
The election of a B cell epitope and a T cell epitope did not refer to any length limit, therefore, claim 7 was withdrawn. A species does not necessarily fall within a genus. In addition, applicants were instructed to elect a single, specific species.
Applicants should provide the structure of PEG-3000 if they wish for a claim to be considered (i.e. claim 14). Please note: applicants may NOT make a different election (see page 6, claim 14 section).
Again, regarding claims 25-30, an election of a genus (i.e. supermolecular complex) does not necessarily encompass a species. In addition, applicants were instructed to elect a single, specific species.
Regarding claims 20, 21, and new claim 37, applicants may not alter an election by original presentation during prosecution. If applicants did not understand the election requirement, applicants should have called the examiner of record for clarification.
Applicants elected, with traverse, a conjugate that elicits a T cell response in the reply filed on December 1, 2023. The traversal is on the grounds that a serious search burden does not exist. This is not found persuasive because the present is a 371 (National Stage), therefore, the art of record utilized to break Unity of Invention should be argued. Furthermore, applicants were not limited to electing a species of T cell response or antibody response just as applicants were not limited to elect a T cell epitope or a B cell antigen for species B. The requirement is still deemed proper and is therefore made FINAL. Claims 20 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 1, 2023.
The election of species has been made FINAL. Applicants should NOT continue to traverse the species particularly since the original election of species was made WITHOUT traverse (for the majority of the species elections).
Priority
The present application is a 371 (National Stage) of PCT/US2018/042762 filed July 18, 2018 which claims the benefit of 62/533,910 filed July 18, 2017.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Withdrawn Rejections
The rejection of claims 1, 2 , 5, 8, 9, 11, 12, 16-18, 21, and 24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement regarding SEQ ID NO: 19 is withdrawn in view of the amendment received January 15, 2026 which deleted SEQ ID NO: 19 from the claims.
Maintained Rejections and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Support in the originally found specification was not found for “at least one peptide epitope” (see independent claim 1); “at least one peptide epitope” (see claim 8); or “at least one peptide epitope” (see claim 9). Applicants pointed to paragraph 67 to support the claim amendments received December 1, 2023. However, paragraph 67 discusses the types of epitopes/antigens and not the number of epitopes/antigens.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(a) (new matter), for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that since paragraph 35 states that “a”, “and”, and “the” include plural references and paragraph 66 refers to the peptide epitope that support is found in the originally filed specification.
Applicants’ arguments are not convincing since support in the originally filed specification is required for the structure required in the present claims (e.g. epitope-epitope-epitope-self assembling domain-PEG; epitope-epitope-epitope-epitope-epitope-self assembling domain-PEG). The generic statements regarding “a”, “and”, and “the” are not enough to provide support for an open-ended range of “at least one”. In addition, paragraph 35 reads “The singular forms “a,” “and” and “the” include plural references unless the context clearly dictates otherwise.” Thus, it appears that the blanket statement regarding the plurality is not always controlling.
Below is the text of paragraph 66 of the original specification.
[00066] In some embodiments, the peptide-polymer conjugate comprises a protein antigen. The protein antigen may comprise a polypeptide of 10 to 500 amino acids. In some embodiments, the peptide epitope is comprised within a protein antigen. In some embodiments, the peptide epitope is a portion of a protein antigen. The protein antigen may be linked to the N-terminal end or the C-terminal end of the self-assembling domain. In some embodiments, the protein antigen is linked to the N-terminal end of the self- assembling domain. In some embodiments, the protein antigen is linked to the C-terminal end of the self-assembling domain. In some embodiments, the protein antigen is immunogenic. In some embodiments, the protein antigen is antigenic.
This does not provide support for the open-ended range of “at least one peptide epitope”.
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of SEQ ID NOs: 1, 2, 23, 24, 25, 26, 27, 28, 29, 30, 34, 35, 36, 37, 52, 53, 54, 55, 56, 57, 58, 59, 60, 62, 63, and 64 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: SEQ ID NOs: 1, 2, 23, 24, 25, 26, 27, 28, 29, 30, 34, 35, 36, 37, 52, 53, 54, 55, 56, 57, 58, 59, 60, 62, 63, and 64 do not share a common core structure/domain/etc. and a common use. Please note: SEQ ID NOs: 1 and 2 share a common core structure; SEQ ID NOs: 23-25 share a common core structure; SEQ ID NOs: 27-29 share a common core structure; SEQ ID NOs: 35 and 36 share a common core structure; SEQ ID NOs: 52-56, 58, and 64 share a common core structure; SEQ ID NOs: 57, 59, and 60 share a common core structure. See Table 1 in the originally filed specification (pages 18-20).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Arguments and Response
Applicants’ arguments directed to the rejection under improper Markush grouping of alternatives, for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that because there is a common use (i.e. beta sheet and alpha helix formation) the rejection is moot.
Applicants’ arguments are not convincing since the structural features of beta sheet and alpha helix are not a common use (i.e. forming beta sheets is one common use and forming alpha helixes is a separate common use). In addition, the Markush members must have BOTH a common use AND a single structural similarity. Many of the sequences that form beta sheets do not share a common core structure.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Collier et al. U.S. Patent Application Publication 2012/0282292 published November 8, 2012 and Ingber et al. U.S. Patent Application Publication 2015/0218252 published August 6, 2015.
For present claims 1, 2, 5, 6, 8, 9, 11, 16-18, 21, and 24, Collier et al. teach fibrillar adjuvants comprising a self-assembled peptide QQKFQFQFEQQ (SEQ ID NO: 1; present SEQ ID NO: 1) which self-assembles into b sheets and nanofibers wherein the length is 0.25-100 mm and the width is about 15 nm with antigen/epitope conjugated to the N- or C-terminus including OVA which has both B cell and T cell epitopes and elicits a T cell response and utilizing linkers including Ser-Gly-Ser-Gly (present SEQ ID NO: 4) and pluralities of the above (please refer to the entire specification particularly the abstract; Figures 1, 2; paragraphs 6, 8-13, 15, 32-37, 39-48; Table 1; Examples; claims). Collier et al. also teach utilizing polyethylene glycol (PEG) as a carrier (please refer to the entire specification particularly paragraphs 61, 64).
Thus, Collier et al. teach peptide epitope-(self-assembling peptide) or (self-assembling peptide)-epitope.
However, while Collier et al. teach PEG as a carrier, Collier et al. do not specifically teach conjugation of PEG to the nanofibers.
For present claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24, Ingber et al. teach self-assembling peptides conjugated to PEG as linkers or to increase half-life in vivo and conjugation of antigens to self-assembling peptides (please refer to the entire specification particularly the abstract; paragraphs 3, 19, 22, 25-27, 45, 46, 50, 69, 70, 76, 77, 79, 112, 113, 132-134, 136, 174-176, 194, 196, 198).
Thus, Ingber et al. teach PEG-(self-assembling peptide) or (self-assembling peptide)-PEG with the addition of an antigen to the self-assembling peptide.
Regarding the MW of PEG, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); and Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
The claims would have been obvious because a particular known technique (i.e. conjugation of PEG to self-assembling peptides to increase half-life in vivo; utilization of PEG as a linker in fusion polypeptides, etc.) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” (e.g. PEGylation of peptides to increase in vivo half-life is a well-understood, routine, and conventional method in the art). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Collier et al. and Ingber et al. for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that Collier et al. and Ingber et al. do not teach a construct that includes both an antigen/epitope and PEG particularly since Ingber et al. do not teach both PEG and an antigen. Applicants argue the references individually.
Applicants’ arguments are not convincing since the teachings of Collier et al. and Ingber et al. render the peptide-polymer conjugate of the instant claims prima facie obvious.
The present peptide-polymer conjugate has one of two structures:
peptide epitope-(self-assembling domain)-PEG or
PEG-(self-assembling domain)-peptide epitope.
Paragraph 11 of Ingber et al. teach a self-assembling peptide (i.e. isolated peptide – see paragraphs 6-10) can be conjugated to a ligand (i.e. PEG), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), and any combinations thereof.
Paragraph 19 of Ingber et al. teach the amino acid sequence (i.e. self-assembling peptide – see paragraphs 14-18) can be conjugated to a ligand including an antigen.
Paragraph 91 of Ingber et al. teach that the self-assembling peptide can be conjugated to one or more entities described herein (i.e. antigen, epitope, PEG) including a linker (PEG), a ligand (i.e. PEG, epitope), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), etc.
Paragraph 113 refers to PEG as a ligand.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Collier et al. teach a self-assembling peptides conjugated to antigens and PEG as a carrier but not specifically conjugated to a self-assembling peptide (see above). Ingber et al. teach self-assembling peptides conjugated to PEG (see above). PEG in both Collier et al. and Ingber et al. is utilized to increase half-life. The examiner of record would like to thank applicants for specifically pointing out that Ingber et al. also teach conjugation of self-assembling peptides to antigens (see paragraph 19).
The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Collier et al. U.S. Patent Application Publication 2014/0273148 published September 18, 2014 and Ingber et al. U.S. Patent Application Publication 2015/0218252 published August 6, 2015.
For present claims 1, 2, 5, 6, 8, 9, 11, 16-18, 21, and 24, Collier et al. teach fibrillar adjuvants comprising a self-assembled peptide QQKFQFQFEQQ (SEQ ID NO: 6; present SEQ ID NO: 1) which self-assembles into b sheets and nanofibers wherein the length is 1-100 mm and the size/length/diameter is 100 nm or less with B cell and/or T cell antigen/epitope conjugated to the N- or C-terminus and utilizing linkers including SGSG (present SEQ ID NO: 4) and pluralities of the above (please refer to the entire specification particularly the abstract; Figures 1, 4A, 4B, 8A; paragraphs 5-25, 29-32, 34-36, 56-58, 66-94, 100-102, 124, 125, 148-150, 153-155, 159, 171, 172; claims). Collier et al. also teach utilizing polyethylene glycol (PEG) as a carrier, cell delivery matrix, or as a tag for peptide purification (please refer to the entire specification particularly paragraphs 115, 119, 128, 144).
Thus, Collier et al. teach peptide epitope-(self-assembling peptide) or (self-assembling peptide)-epitope.
However, while Collier et al. teaches PEG as a carrier, Collier et al. do not specifically teach conjugation of PEG to the nanofibers.
For present claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24, Ingber et al. teach self-assembling peptides conjugated to PEG as linkers or to increase half-life in vivo and conjugation of self-assembling peptides to antigens (please refer to the entire specification particularly the abstract; paragraphs 3, 19, 22, 25-27, 45, 46, 50, 69, 70, 76, 77, 79, 112, 113, 132-134, 136, 174-176, 194, 196, 198).
Thus, Ingber et al. teach PEG-(self-assembling peptide) or (self-assembling peptide)-PEG with the addition of an antigen to the self-assembling peptide.
Regarding the MW of PEG, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); and Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
The claims would have been obvious because a particular known technique (i.e. conjugation of PEG to self-assembling peptides to increase half-life in vivo; utilization of PEG as a linker in fusion polypeptides, etc.) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” (e.g. PEGylation of peptides to increase in vivo half-life is a well-understood, routine, and conventional method in the art). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Collier et al. and Ingber et al. for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that Collier et al. and Ingber et al. do not teach a construct that includes both an antigen/epitope and PEG particularly since Ingber et al. do not teach both PEG and an antigen. Applicants argue the references individually.
Applicants’ arguments are not convincing since the teachings of Collier et al. and Ingber et al. render the peptide-polymer conjugate of the instant claims prima facie obvious.
The present peptide-polymer conjugate has one of two structures:
peptide epitope-(self-assembling domain)-PEG or
PEG-(self-assembling domain)-peptide epitope.
Paragraph 11 of Ingber et al. teach a self-assembling peptide (i.e. isolated peptide – see paragraphs 6-10) can be conjugated to a ligand (i.e. PEG), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), and any combinations thereof.
Paragraph 19 of Ingber et al. teach the amino acid sequence (i.e. self-assembling peptide – see paragraphs 14-18) can be conjugated to a ligand including an antigen.
Paragraph 91 of Ingber et al. teach that the self-assembling peptide can be conjugated to one or more entities described herein (i.e. antigen, epitope, PEG) including a linker (PEG), a ligand (i.e. PEG, epitope), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), etc.
Paragraph 113 refers to PEG as a ligand.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Collier et al. teach a self-assembling peptides conjugated to antigens and PEG as a carrier but not specifically conjugated to a self-assembling peptide (see above). Ingber et al. teach self-assembling peptides conjugated to PEG (see above). PEG in both Collier et al. and Ingber et al. is utilized to increase half-life. The examiner of record would like to thank applicants for specifically pointing out that Ingber et al. also teach conjugation of self-assembling peptides to antigens (see paragraph 19).
The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Collier et al. U.S. Patent Application Publication 2016/0074509 published March 17, 2016 and Ingber et al. U.S. Patent Application Publication 2015/0218252 published August 6, 2015.
For present claims 1, 2, 5, 6, 8, 9, 11, 16-18, 21, and 24, Collier et al. teach fibrillar adjuvants comprising a self-assembled peptide QQKFQFQFEQQ (SEQ ID NO: 1; present SEQ ID NO: 1) which self-assembles into b sheets and nanofibers wherein the length is 0.01-100 mm with antigen/epitope conjugated to the N- or C-terminus including OVA which has both B cell and T cell epitopes and elicits a T cell response and utilizing linkers including SGSG (SEQ ID NO: 61; present SEQ ID NO: 4) and pluralities of the above (please refer to the entire specification particularly the abstract; Figures 1A, 1B, 2, 8A, 8B, 9A-9F; paragraphs 5, 7-15, 18, 45-53, 55-69, 95, 98, 99, 125-127, 130, 131; Table 1; Examples; claims). Collier et al. also teach utilizing polyethylene glycol (PEG) as a carrier and utilizing PEG to purify peptides (please refer to the entire specification particularly paragraphs 86, 121).
Thus, Collier et al. teach peptide epitope-(self-assembling peptide) or (self-assembling peptide)-epitope.
However, while Collier et al. teaches PEG as a carrier, Collier et al. do not specifically teach conjugation of PEG to the nanofibers.
For present claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24, Ingber et al. teach self-assembling peptides conjugated to PEG as linkers or to increase half-life in vivo and conjugations of self-assembling peptides to antigens (please refer to the entire specification particularly the abstract; paragraphs 3, 19, 22, 25-27, 45, 46, 50, 69, 70, 76, 77, 79, 112, 113, 132-134, 136, 174-176, 194, 196, 198).
Thus, Ingber et al. teach PEG-(self-assembling peptide) or (self-assembling peptide)-PEG with the addition of an antigen to the self-assembling peptide.
Regarding the MW of PEG, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); and Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
The claims would have been obvious because a particular known technique (i.e. conjugation of PEG to self-assembling peptides to increase half-life in vivo; utilization of PEG as a linker in fusion polypeptides, etc.) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” (e.g. PEGylation of peptides to increase in vivo half-life is a well-understood, routine, and conventional method in the art). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Collier et al. and Ingber et al. for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that Collier et al. and Ingber et al. do not teach a construct that includes both an antigen/epitope and PEG particularly since Ingber et al. do not teach both PEG and an antigen. Applicants argue the references individually.
Applicants’ arguments are not convincing since the teachings of Collier et al. and Ingber et al. render the peptide-polymer conjugate of the instant claims prima facie obvious.
The present peptide-polymer conjugate has one of two structures:
peptide epitope-(self-assembling domain)-PEG or
PEG-(self-assembling domain)-peptide epitope.
Paragraph 11 of Ingber et al. teach a self-assembling peptide (i.e. isolated peptide – see paragraphs 6-10) can be conjugated to a ligand (i.e. PEG), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), and any combinations thereof.
Paragraph 19 of Ingber et al. teach the amino acid sequence (i.e. self-assembling peptide – see paragraphs 14-18) can be conjugated to a ligand including an antigen.
Paragraph 91 of Ingber et al. teach that the self-assembling peptide can be conjugated to one or more entities described herein (i.e. antigen, epitope, PEG) including a linker (PEG), a ligand (i.e. PEG, epitope), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), etc.
Paragraph 113 refers to PEG as a ligand.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Collier et al. teach a self-assembling peptides conjugated to antigens and PEG as a carrier but not specifically conjugated to a self-assembling peptide (see above). Ingber et al. teach self-assembling peptides conjugated to PEG (see above). PEG in both Collier et al. and Ingber et al. is utilized to increase half-life. The examiner of record would like to thank applicants for specifically pointing out that Ingber et al. also teach conjugation of self-assembling peptides to antigens (see paragraph 19).
The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent 12,290,603 (previously copending Application No. 17/764,406). Although the claims at issue are not identical, they are not patentably distinct from each other because both the presently claimed product and the product as claimed in U.S. Patent 12,290,603 are drawn to peptide-polymer conjugates comprising a self-assembling peptide, an epitope or antigen, and PEG.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent 12,290,603 for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
While a TD was filed on January 15, 2026, the incorrect form was submitted. Therefore, the TD was disapproved. Applicants should utilize form PTO/AIA /25 (04-13) for a pending application and form PTO/AIA /26 (04-15) for a prior patent.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent 12,290,603 renders obvious the peptide-polymer conjugate of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 9, 11, 12, 14, 17-21, 23, 24, 32, 36, and 39 of claims 1-20 of U.S. Patent 12,290,603 (previously copending Application No. 17/608,443) in view of Ingber et al. U.S. Patent Application Publication 2015/0218252 published August 6, 2015.
Both the presently claimed product and the product of U.S. Patent 12,290,603 are drawn to a self-assembling peptide which forms b sheets and nanofibers, spacers and “random” peptide (e.g. epitope or antigen).
Ingber et al. teach self-assembling peptides conjugated to PEG as linkers or to increase half-life in vivo (please refer to the entire specification particularly the abstract; paragraphs 3, 22, 25-27, 45, 46, 50, 69, 70, 76, 77, 79, 112, 113, 132-134, 136, 174-176, 194, 196, 198).
Thus, Ingber et al. teach PEG-(self-assembling peptide) or (self-assembling peptide)-PEG with the addition of an antigen to the self-assembling peptide.
Regarding the MW of PEG, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); and Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
The claims would have been obvious because a particular known technique (i.e. conjugation of PEG to self-assembling peptides to increase half-life in vivo; utilization of PEG as a linker in fusion polypeptides, etc.) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” (e.g. PEGylation of peptides to increase in vivo half-life is a well-understood, routine, and conventional method in the art). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent 12,290,603 in view of Ingber et al. for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
While a TD was filed on January 15, 2026, the incorrect form was submitted. Therefore, the TD was disapproved. Applicants should utilize form PTO/AIA /25 (04-13) for a pending application and form PTO/AIA /26 (04-15) for a prior patent.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent 12,290,603 in view of Ingber et al. renders obvious the peptide-polymer conjugate of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,246,924 in view of Ingber et al. U.S. Patent Application Publication 2015/0218252 published August 6, 2015.
Both the present claims and the claims of U.S. Patent No. 11,246,924 are drawn to self-assembling peptides which form a nanofiber coupled to antigens.
Ingber et al. teach self-assembling peptides conjugated to PEG as linkers or to increase half-life in vivo (please refer to the entire specification particularly the abstract; paragraphs 3, 22, 25-27, 45, 46, 50, 69, 70, 76, 77, 79, 112, 113, 132-134, 136, 174-176, 194, 196, 198).
Thus, Ingber et al. teach PEG-(self-assembling peptide) or (self-assembling peptide)-PEG with the addition of an antigen to the self-assembling peptide.
Regarding the MW of PEG, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977); In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); and Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
The claims would have been obvious because a particular known technique (i.e. conjugation of PEG to self-assembling peptides to increase half-life in vivo; utilization of PEG as a linker in fusion polypeptides, etc.) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” (e.g. PEGylation of peptides to increase in vivo half-life is a well-understood, routine, and conventional method in the art). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,246,924 in view of Ingber et al. for claims 1, 2, 5, 6, 8, 9, 11, 12, 16-18, 21, and 24 were considered but are not persuasive for the following reasons.
Applicants contend that Ingber et al. do not teach both PEG and an antigen attached to a self-assembling peptide.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,246,924 in view of Ingber et al. renders obvious the peptide-polymer conjugate of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
The present peptide-polymer conjugate has one of two structures:
peptide epitope-(self-assembling domain)-PEG or
PEG-(self-assembling domain)-peptide epitope.
Paragraph 11 of Ingber et al. teach a self-assembling peptide (i.e. isolated peptide – see paragraphs 6-10) can be conjugated to a ligand (i.e. PEG), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), and any combinations thereof.
Paragraph 19 of Ingber et al. teach the amino acid sequence (i.e. self-assembling peptide – see paragraphs 14-18) can be conjugated to a ligand including an antigen.
Paragraph 91 of Ingber et al. teach that the self-assembling peptide can be conjugated to one or more entities described herein (i.e. antigen, epitope, PEG) including a linker (PEG), a ligand (i.e. PEG, epitope), a therapeutic agent (i.e. epitope), a binding molecule (i.e. epitope), etc.
Paragraph 113 refers to PEG as a ligand.
The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication 2015/0031127
Shah et al., July 5, 2016, In vivo Evaluation of Site-specifically PEGylated Chemically Self-assembled Protein Nanostructures, Mol Pharm, 13(7): 2193-2203.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658